FDA moves to make hysterectomy procedure safer

Barbara Leary went in for what was supposed to be routine surgery for fibroids. What doctors didn't know before the surgery was that she had a rare form of cancer. Part of her minimally invasive surgery involved mincing the tissue to take it out through incisions no wider than a drinking straw.

That procedure, called morcellation, spread her cancer.

Mrs. Leary's original surgery was in 2009. She died in September 2013.

On April 17, the Food and Drug Administration issued an alert regarding power morcellation that is used in minimally invasive gynecological surgery. The FDA stopped short of saying, "Don't do it," but for the first time the agency in charge of making sure products, devices and procedures that are supposed to help us issued a warning against a procedure that evidence is showing can hurt.

The FDA officially "discouraged" morcellation. According to the agency, "If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids."

"I'm lost for words," widower Jim Leary said upon hearing about the FDA's action. "That is really great."

Leary was among thousands of family members, and the women themselves, who signed a petition on Change.org, started by a Boston doctor and husband of a woman who underwent minimally invasive surgery last fall, only to find out she had a cancer that had been spread by morcellation.

Dr. Hooman Noorchashm has been relentless ever since, imploring the FDA, senators, the heads of medical organizations to stop the process of morcellation. According to data Noorchashm reported, the risk of having an undetected cancer spread by morcellation was 1 in 400 to 1 in 1000. The FDA reported that risk as great as 1 in 350.

Last month, UR Medicine became only the second health system in the country to put restrictions on the procedure. It will allow morcellation only when done in a containment bag. Rochester General and Unity health systems had yet to make an announcement about whether and how they would continue to allow morcellation.

According to a statement from Dr. Eva Pressman, head of ob/gyn at University of Rochester Medical Center: "The FDA's safety notice on the use of laparoscopic power morcellation, issued (April 17), is consistent with the new guideline we put into place on March 24, which states: Given concerns for spread of occult cancer, intraperitoneal power morcellation will only be allowed inside of containment bags. If this is not technically possible, specimens can be removed from the abdominal cavity using non-power morcellation or intact through larger incisions in the abdomen or vagina.

The FDA acknowledged that move. "Be aware that some clinicians and medical institutions now advocate using a specimen "bag" during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis."

Noorchashm also called the FDA decision a great win, but said the fight wasn't over.

Realizing there is more work to do, the FDA is continuing to study the issue and may have stronger wording.

According to FDA press officer Jennifer Rodriguez, "Some clinicians and medical institutions now advocate using a specimen "bag" during morcellation in an attempt to contain the uterine tissue being morcellated and minimize the risk of spread in the abdomen and pelvis. There is some evidence, which the FDA is reviewing in greater detail, to suggest that specimen bags can reduce the spread of morcellated tissue. For example, there are reports that specimen bags have contained cancerous cells after morcellation of cancerous tissue, suggesting reduction in the risk of dissemination.

"The FDA is still in the process of looking into benefits and risks associated with the morcellation bags. The risks and benefits of using morcellator bags is another aspect of this issue that health care practitioners must carefully consider and discuss with patients.

"These bags are made of plastic, which can rip and/or be torn by sharp instruments. In fact, some manufacturers contraindicate use of their bags with power morcellator and other sharp instruments. Due to a lack of data on the ability of specimen bags to reduce the spread of cancerous tissue and risks with sharp instruments, the FDA is currently focusing its communication efforts on the use of power morcellation.

"The topic of specimen containment bags will be addressed during the panel meeting."

The FDA also wants to hear from you. "If you suspect that a morcellator and/or specimen bag has malfunctioned or contributed to a serious injury or adverse outcome," it writes, report it here.